Jeffrey Crowley1, Diamant Thaçi2, Pascal Joly3, Ketty Peris4, Kim A Papp5, Joana Goncalves6, Robert M Day6, Rongdean Chen6, Kamal Shah6, Carlos Ferrándiz7, Jennifer C Cather8. 1. Bakersfield Dermatology, Bakersfield, California. Electronic address: Crowley415@aol.com. 2. Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Germany. 3. Department of Dermatology, Hôpital Charles Nicolle, Université de Rouen, Rouen, France; Institut National de la Santé et de la Recherche Médicale U519, Rouen, France. 4. Catholic University of Rome, Rome, Italy. 5. Probity Medical Research, Waterloo, Ontario, Canada. 6. Celgene Corporation, Summit, New Jersy. 7. Hospital Universitario Germans Trias i Pujol, Badalona, Universidad Autónoma de Barcelona, Barcelona, Spain. 8. Modern Research Associates, Dallas, Texas.
Abstract
BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVE: Assess long-term safety of oral apremilast in psoriasis patients. METHODS: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. RESULTS: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to ≥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported. LIMITATIONS: This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns. CONCLUSIONS: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
RCT Entities:
BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVE: Assess long-term safety of oral apremilast in psoriasispatients. METHODS: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. RESULTS: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to ≥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported. LIMITATIONS: This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns. CONCLUSIONS: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
Authors: Afroditi Boulougoura; Erin Gabriel; Elizabeth Laidlaw; Vikram Khetani; Ken Arakawa; Jeanette Higgins; Adam Rupert; Robert J Gorelick; Keith Lumbard; Alice Pau; April Poole; Angela Kibiy; Princy Kumar; Irini Sereti Journal: Open Forum Infect Dis Date: 2019-06-03 Impact factor: 3.835
Authors: Kristin Helene Skullerud; Petter Gjersvik; Are Hugo Pripp; Erik Qvigstad; Anne Lise Ording Helgesen Journal: Trials Date: 2021-07-20 Impact factor: 2.279